AzurRx BioPharma Announces Positive Phase 2 Trial Results of MS1819

AzurRx BioPharma (NASDAQ:AZRX) has announced positive safety results from its Phase 2 OPTION Clinical Trial of MS1819 to treat exocrine pancreatic insufficiency in cystic fibrosis patients.

As quoted in the press release:

Results showed that the primary efficacy endpoint of coefficient of fat absorption (CFA) was comparable to the CFA in a prior phase 2 study in patients with chronic pancreatitis, while using the same dose of MS1819.  The dose used in both studies was 2 gram/day, which was selected in agreement with FDA as a bridging dose. Although the study was not powered for statistical significance, the data also demonstrated meaningful efficacy results, with approximately 50% of the patients showing CFAs high enough to reach non-inferiority with porcine enzyme replacement therapies (PERT).

Also, coefficient of nitrogen absorption (CNA) was comparable between the MS1819 and PERT arms, 93% vs. 97%, respectively, in the OPTION trial.  This important finding confirms that protease supplementation is not likely to be required with MS1819 treatment.

“We are thrilled to have seen such favorable safety and meaningful efficacy data in this Phase II study.  Importantly, the data were consistent and confirm results seen in prior clinical studies. We are grateful to all the investigators who worked diligently to bring this study to completion on time and also want to thank the patients and their caregivers for taking the time to participate in the trial,” said Jim Pennington, M.D., Chief Medical Officer of AzurRx. “We are eager to move forward with what we consider a logical and promising next trial to increase the dose for CF patients.”

“The search for a non-porcine based pancreatic enzyme replacement for patients with cystic fibrosis has been a challenging but important endeavor,” said Dr. Michael Konstan, Professor of Pediatrics at Case Western Reserve University School of Medicine, and principal investigator in the OPTION trial.  “With these data showing MS1819 to be safe and to have the potential to support fat absorption, we have considerable reason to be optimistic for the next steps in non-porcine enzyme development.”

Click here to read the full press release.